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Behavioral Intervention

Internet-Delivered CBT for Migraine (I-SPY-RCT Trial)

N/A

Waitlist Available

Led By Emily Law, PhD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

11-17 years old

Be younger than 18 years old

Must not have

Diagnosed sleep disorder (e.g. sleep apnea, narcolepsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether CBT for insomnia can help reduce symptoms and disability related to migraines in adolescents.

Who is the study for?

This trial is for adolescents aged 11-17 who have had headaches for at least three months and insomnia symptoms in the past month. They must be able to use the internet, speak English, read at a 5th grade level or higher, and complete surveys on their own. Those with diagnosed sleep disorders like apnea or narcolepsy, serious conditions such as diabetes or cancer can't participate.

What is being tested?

The trial tests if online cognitive-behavioral therapy (CBT) can help teens with migraines sleep better and reduce headache pain. It compares CBT for insomnia alone against combined CBT for both insomnia and pain management versus just learning about good sleep habits online.

What are the potential side effects?

Since this study involves non-medical interventions like online education and therapy sessions, side effects are minimal but may include discomfort from discussing personal issues during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 11 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after treatment phase 1, immediately after treatment phase 2, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in headache-related disability

Change in insomnia symptoms

Secondary study objectives

Change in anxiety symptoms

Change in depressive symptoms

Change in headache frequency

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT for Insomnia + CBT for PainExperimental Treatment2 Interventions

Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Group II: Sleep Education + CBT for PainActive Control2 Interventions

Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

0 / 2Eligibility criteria met